SSPC3 Delivery Catheter

GUDID 00810024671830

Catheter and Dilator

CENTERPOINT SYSTEMS LLC

Pacing/defibrillation lead delivery catheter

• Primary Device ID: 00810024671830
• NIH Device Record Key: 6c68e41e-77dd-4f6e-808f-7b7300b0dcdf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SSPC3 Delivery Catheter
• Version Model Number: 9183
• Company DUNS: 117126091
• Company Name: CENTERPOINT SYSTEMS LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-848-0828
• Email: info@centerpoint-systems.com

Device Dimensions

• Catheter Working Length: 40 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not store in direct sunlight

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810024671830 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190475

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-08-29
• Device Publish Date: 2019-08-21

Devices Manufactured by CENTERPOINT SYSTEMS LLC

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• 00810024670291 - Helix Locking Tool: 2024-03-25
• 00810024670116 - CPS Locator 3D, Large Delivery System: 2023-03-27 Catheter and dilator
• 00810024670123 - CPS Locator 3D, Medium Delivery Catheter: 2023-03-27 Delivery Catheter and dilator
• 00810024670130 - CPS Locator 3D Small Delivery Catheter: 2023-03-27 Delivery catheter & dilator
• 00810024670147 - CPS Locator 3D Large Extra Long Delivery Catheter: 2023-03-27 Delivery catheter and dilator
• 00810024670154 - CPS Locator 3D Medium Extra Long Delivery Catheter: 2023-03-27 Delivery catheter & dilator